CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

Trial ID or NCT#

NCT03179800

Status

not recruiting iconNOT RECRUITING

Purpose

The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.

Official Title

CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

Eligibility Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Mean 24 hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed, (JNC8) or their equivalent when those listed are not available dosing regimen consisting of up to 5 antihypertensive medications, with a minimum required dosing regimen of an "A+C+D" antihypertensive medication regimen, where "A" is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, "C" is a calcium channel blocker, and "D" is a diuretic.
Exclusion Criteria:
  1. * Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.
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Investigator(s)

Tara I. Chang
Tara I. Chang
Nephrologist - Kidney specialist, Refractory hypertension specialist, Heart and kidney disease specialist, Nephrologist
Stanford University Professor of Nephrology

View on ClinicalTrials.gov